Use of Clinical Global Impressions-Severity (CGI-S) to Assess Response to Antidepressant Treatment in Patients with Treatment-Resistant Depression

Overview

Journal Neuropsychiatr Dis Treat

Publisher Dove Medical Press

Specialty Psychiatry

Date 2022 Jun 16

PMID 35707064

Authors

Joachim Morrens

Maju Mathews

Vanina Popova

Stephane Borentain

Benoit Rive

Beatriz Gonzalez Martin Moro

Carol Jamieson

Qiaoyi Zhang

Affiliations

Soon will be listed here.

Abstract

Background: This post-hoc analysis evaluated the agreement between Clinical Global Impressions-Severity (CGI-S) score- and Montgomery-Åsberg Depression Rating Scale (MADRS) total score-based assessment of response in patients with treatment-resistant depression (TRD) treated with esketamine nasal spray plus a newly initiated oral antidepressant (ESK-NS + AD).

Methods: Data were analyzed from a phase 3, randomized, double-blind study (TRANSFORM-2) of flexibly dosed esketamine or placebo nasal spray plus a newly initiated oral-AD in adults with moderate-to-severe TRD. Patients with ≥50% reduction in MADRS from baseline at the end of the 4-week acute treatment phase were defined as responders. For the CGI-S-based assessment of response, patients with ≥2 points decrease from baseline or a CGI-S score of ≤3 (mildly depressed to normal) were considered responders. Cohen's kappa coefficient was calculated to assess level of agreement between MADRS and CGI-S-based assessments.

Results: At the end of 4-week treatment, the proportion of responders among all study patients (n=201) was similar when assessed using the MADRS (61%) and CGI-S (62%) methods, with substantial agreement (Cohen's kappa=0.76; sensitivity=92%; specificity=84%) between both methods. When restricting analysis to ESK-NS + AD-treated patients (n=101) who had a higher response rate (on MADRS: 69%; on CGI-S: 68%), the agreement remained substantial (Cohen's kappa=0.75; sensitivity=91%; specificity=84%).

Conclusion: The CGI-S may be a practical and reliable alternative to the MADRS to assess response to ESK-NS + AD in patients with TRD and can be used in real-world practice to support informed treatment decisions.

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References

Fedgchin M, Trivedi M, Daly E, Melkote R, Lane R, Lim P . Efficacy and Safety of Fixed-Dose Esketamine Nasal Spray Combined With a New Oral Antidepressant in Treatment-Resistant Depression: Results of a Randomized, Double-Blind, Active-Controlled Study (TRANSFORM-1). Int J Neuropsychopharmacol. 2019; 22(10):616-630. PMC: 6822141. DOI: 10.1093/ijnp/pyz039. View

Hudgens S, Floden L, Blackowicz M, Jamieson C, Popova V, Fedgchin M . Meaningful Change in Depression Symptoms Assessed with the Patient Health Questionnaire (PHQ-9) and Montgomery-Åsberg Depression Rating Scale (MADRS) Among Patients with Treatment Resistant Depression in Two, Randomized, Double-blind,.... J Affect Disord. 2020; 281:767-775. DOI: 10.1016/j.jad.2020.11.066. View

Harding K, Rush A, Arbuckle M, Trivedi M, Pincus H . Measurement-based care in psychiatric practice: a policy framework for implementation. J Clin Psychiatry. 2011; 72(8):1136-43. DOI: 10.4088/JCP.10r06282whi. View

Wajs E, Aluisio L, Holder R, Daly E, Lane R, Lim P . Esketamine Nasal Spray Plus Oral Antidepressant in Patients With Treatment-Resistant Depression: Assessment of Long-Term Safety in a Phase 3, Open-Label Study (SUSTAIN-2). J Clin Psychiatry. 2020; 81(3). DOI: 10.4088/JCP.19m12891. View

Kearns N, Cruickshank C, McGuigan K, Riley S, Shaw S, SNAITH R . A comparison of depression rating scales. Br J Psychiatry. 1982; 141:45-9. DOI: 10.1192/bjp.141.1.45. View

Montgomery S, Asberg M . A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979; 134:382-9. DOI: 10.1192/bjp.134.4.382. View

Trivedi M, Daly E . Measurement-based care for refractory depression: a clinical decision support model for clinical research and practice. Drug Alcohol Depend. 2007; 88 Suppl 2:S61-71. PMC: 2793274. DOI: 10.1016/j.drugalcdep.2007.01.007. View

Scott K, Lewis C . Using Measurement-Based Care to Enhance Any Treatment. Cogn Behav Pract. 2016; 22(1):49-59. PMC: 4910387. DOI: 10.1016/j.cbpra.2014.01.010. View

Turkoz I, Alphs L, Singh J, Jamieson C, Daly E, Shawi M . Clinically meaningful changes on depressive symptom measures and patient-reported outcomes in patients with treatment-resistant depression. Acta Psychiatr Scand. 2020; 143(3):253-263. PMC: 7986932. DOI: 10.1111/acps.13260. View

10.

Jones R, Patel K, Moscovici M, McMaster R, Glancy G, Simpson A . Adaptation of the Clinical Global Impression for Use in Correctional Settings: The CGI-C. Front Psychiatry. 2019; 10:687. PMC: 6759827. DOI: 10.3389/fpsyt.2019.00687. View

11.

Leucht S, Fennema H, Engel R, Kaspers-Janssen M, Lepping P, Szegedi A . What does the MADRS mean? Equipercentile linking with the CGI using a company database of mirtazapine studies. J Affect Disord. 2017; 210:287-293. DOI: 10.1016/j.jad.2016.12.041. View

12.

Conway C, Kumar A, Xiong W, Bunker M, Aaronson S, Rush A . Chronic Vagus Nerve Stimulation Significantly Improves Quality of Life in Treatment-Resistant Major Depression. J Clin Psychiatry. 2018; 79(5). DOI: 10.4088/JCP.18m12178. View

13.

Hong R, Murphy J, Michalak E, Chakrabarty T, Wang Z, Parikh S . Implementing Measurement-Based Care for Depression: Practical Solutions for Psychiatrists and Primary Care Physicians. Neuropsychiatr Dis Treat. 2021; 17:79-90. PMC: 7813452. DOI: 10.2147/NDT.S283731. View

14.

Daly E, Trivedi M, Janik A, Li H, Zhang Y, Li X . Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2019; 76(9):893-903. PMC: 6551577. DOI: 10.1001/jamapsychiatry.2019.1189. View

15.

Quilty L, Robinson J, Rolland J, De Fruyt F, Rouillon F, Bagby R . The structure of the Montgomery-Åsberg depression rating scale over the course of treatment for depression. Int J Methods Psychiatr Res. 2013; 22(3):175-84. PMC: 6878407. DOI: 10.1002/mpr.1388. View

16.

Busner J, Targum S . The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2010; 4(7):28-37. PMC: 2880930. View

17.

Khan A, Khan S, Shankles E, Polissar N . Relative sensitivity of the Montgomery-Asberg Depression Rating Scale, the Hamilton Depression rating scale and the Clinical Global Impressions rating scale in antidepressant clinical trials. Int Clin Psychopharmacol. 2002; 17(6):281-5. DOI: 10.1097/00004850-200211000-00003. View

18.

Ochs-Ross R, Daly E, Zhang Y, Lane R, Lim P, Morrison R . Efficacy and Safety of Esketamine Nasal Spray Plus an Oral Antidepressant in Elderly Patients With Treatment-Resistant Depression-TRANSFORM-3. Am J Geriatr Psychiatry. 2019; 28(2):121-141. DOI: 10.1016/j.jagp.2019.10.008. View

19.

Jiang Q, Ahmed S . An analysis of correlations among four outcome scales employed in clinical trials of patients with major depressive disorder. Ann Gen Psychiatry. 2009; 8:4. PMC: 2645397. DOI: 10.1186/1744-859X-8-4. View

20.

Popova V, Daly E, Trivedi M, Cooper K, Lane R, Lim P . Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Combined With a Newly Initiated Oral Antidepressant in Treatment-Resistant Depression: A Randomized Double-Blind Active-Controlled Study. Am J Psychiatry. 2019; 176(6):428-438. DOI: 10.1176/appi.ajp.2019.19020172. View